October is just around the corner, and anticipation over the new hepatitis C drug is rising. Earlier this year, the U.S. Food and Drug Administration (FDA) granted priority review to Gilead Sciences for a once-daily pill combining ledipasvir and sofosbuvir (Sovaldi) to treat adults with genotype 1 chronic hepatitis C infection. Approval is expected by October 10, 2014. Sovaldi was approved in late 2013, and hepatitis C patients are “slaying dragons,” which is the hepatitis C community’s metaphor for successful treatment. (My apologies to Puff; it isn’t my metaphor.)
Although dragons are dropping like proverbial flies, current treatment with Sovaldi isn’t perfect. Depending on their genotype, patients either need to use interferon and/or ribavirin with Sovaldi. Some patients with advanced disease are taking Olysio and Sovaldi. Technically, this combination isn’t FDA-approved, but it is perfectly legal to prescribe. The results are fantastic, and patients have mild side effects. However, the Olysio/Sovaldi combo is pricey, and the insurance approval process is tedious.
I am assuming that once the ledipasvir/sofosbuvir combo is approved, the process of getting the drug will be straightforward. However, straightforward doesn’t mean fast. Although the FDA must respond by Oct 10, that doesn’t mean the pharmacies and insurance companies will be ready to get the drug to you on that date. Count on a long delay, and if it isn’t long, you will be pleasantly surprised.
We don’t know if the FDA will approve the ledipasvir/sofosbuvir combo for 8 weeks or 12 weeks. If treatment is for 12 weeks, and if you don’t get the drug until late October or early November, check your health insurance plan. If you have a deductible for this medication, you will need to pay that. If you max out your deductible, this will save you some money. However, the deductible is reset on January 1st, so that means you will need to pay it again. From a financial standpoint, some people may want to start in January so they don’t have to pay this twice. Also, be sure your doctor will be participating as a provider in 2014 and 2015. You don’t want to be changing doctors mid-treatment.
Gilead has been generous in helping to reduce patients’ out-of-pocket costs. Check with them before purchasing your medication.
In the meantime, if you are waiting for these new treatments, prepare for this as if you are training for a marathon - get in shape, don’t drink alcohol, lose weight if you need to, exercise daily, enjoy life, and grab the opportunity as if it is the chance of a lifetime. Look in to your insurance plan, and weigh your options. Check with the drug company and be ready to ask for help as soon as your doctor has prescribed treatment for you. Then, go slay that dragon, but stay away from Puff.
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